Novartis confirms growing Gilenya® clinical and real-world experience as number of patients treated increases to over 63,000 Dienstag, 26. März 2013 - 07:16

• Growing global evidence base reinforces consistent and sustained efficacy of first once-daily oral multiple sclerosis treatment
• Up to seven years of clinical trial experience (Phase II and III) and over two years of real-world use
• Gilenya is the only approved MS treatment shown to consistently decrease brain volume loss across studies with a significant effect seen as early as six months
• Low rate of brain volume loss with Gilenya sustained for up to four years in Phase III studies and for up to seven years in patients after completing a Phase II study

Basel, March 26, 2013 - Latest global patient-use data show that Gilenya^® (fingolimod) has been used to treat more than 63,000 patients in clinical trials and the post-marketing setting[1].

"As the first once-daily oral MS therapy, we are pleased Gilenya has played such an important role in addressing unmet medical need in the MS community in the two years following initial approvals," said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. "Our growing experience reinforces Gilenya's high efficacy and very good tolerability profile and Novartis remains committed to ensuring eligible patients have access to Gilenya."

Gilenya is the only approved treatment shown to consistently decrease brain volume loss[2],[3]. Brain volume loss is the best magnetic resonance imaging (MRI) correlate of long-term disability.  New data presented at the recent 65th Annual Meeting American Academy of Neurology (AAN), showed that Gilenya reduced the rate of brain volume loss by about one-third compared to interferon beta-1a IM or placebo in studies with over 3,600 patients with relapsing MS.[4] Patients from a Phase II study who remained on treatment for up to seven years experienced consistently low rates of brain volume loss[5].

Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of six-month disability progression sustained at four years[6]. Nearly half of Gilenya patients were disease-free after one year of treatment[7],[8] and in the pivotal FREEDOMS study, eight out of ten patients on the approved dose remained on treatment at two years[2].

In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile[2],[3].

Gilenya was approved based on the largest phase III clinical trial program in MS at the time of submission, which included a head-to-head study versus Avonex® (interferon beta-1a IM), a commonly prescribed treatment. Gilenya is now approved in 70 countries, and there is approximately 73,000 patient years of exposure[1].

Up to 2.5 million people worldwide are affected with MS[9], a neurodegenerative condition that often begins in early adulthood[10]. Around 70% of newly diagnosed patients with MS are in the prime of their lives - between 20 and 40 years of age - so most people are employed at the time of diagnosis. This can have a significant impact on careers, quality of life and families[11],[12].

About Gilenya
Gilenya is the first oral therapy approved to treat relapsing forms of MS and the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya is thought to act on inflammatory processes implicated in the MS disease process[13],[14].

Gilenya has demonstrated superior efficacy compared to Avonex® (interferon beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction in annualized relapse rate (primary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis[3]. In a post hoc sub-group analysis, Gilenya showed a 61% relative reduction in annualized relapse rate compared to interferon-beta-1a IM at one year in subgroups of patients with highly active relapsing-remitting MS not responding to interferon treatment[15].

In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile[2],[3]. The most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction[2],[3]. The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups[2],[3].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "committed," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Gilenya or regarding potential future revenues from Gilenya. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Gilenya to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gilenya will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Gilenya will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Gilenya could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general, including potential competition from additional newly-approved oral multiple sclerosis treatments; unexpected regulatory actions or delays or government regulation generally; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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References:
[1] Data on file. Novartis Pharma AG.
[2] Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401.
[3] Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-415
[4] Cohen J. et al. Fingolimod-effect on brain atrophy and clinical/MRI correlations in Three Phase 3 studies - TRANSFORMS, FREEDOMS and FREEDOMS II. Abstract Presented at AAN, San Diego, March 2013.
[5] Chin PS, Calabresi PA, Zhang Y, von Rosenstiel P, Kappos L. Early effect of fingolimod on clinical and MRI related outcomes in relapsing multiple sclerosis. Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Abstract P459
[6] Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720) efficacy in patients with relapsing-remitting multiple sclerosis receiving continuous or placebo-fingolimod switched therapy for up to 4 years. Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Poster P979.
[7] Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis compared to interferon beta-1a: results from a phase 3 activecontrolled study (TRANSFORMS). Abstract presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract PD5:006.
[8] Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis compared to interferon beta-1a: results from a phase 3 active-controlled study (TRANSFORMS). Poster presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Poster PD5:006.
[9] Multiple Sclerosis International Federation. Atlas of MS [online]. Available at: www.atlasofms.org. Accessed January 2013.
[10] Declaration of the European Parliament of 13 September 2012 on tackling multiple sclerosis in Europe http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2012-0357&format=XML&language=EN. Accessed January 2013.
[11] European Multiple Sclerosis Platform, MS fact sheet 2011 http://www.ms-in-europe.org/multiple-sclerosis/index.php?kategorie=whatisms&cnr=6&anr=127. Accessed January 2013.
[12] Multiple Sclerosis Factsheet http://www.emsp.org/ms-need/content/factsheet.pdf Accessed January 2013.
[13] Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects in the immune and the central nervous system. Br J Pharmacol 2009;158(5):1173-1182.
[14] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 Mar-Apr;33(2):91-101.
[15] Havrdová E. et al. Clinical outcomes in subgroups of patients with highly action relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720): Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at ECTRIMS, Amsterdam, October 2011.

Avonex® is a registered trademark of Biogen Idec.

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